Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 7:14 PM
Study NCT ID:
NCT00130260
Status:
TERMINATED
Last Update Posted:
2008-01-04
First Post:
2005-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Third and Fourth Dose of StaphVAX® in Adults With End-Stage Renal Disease
Sponsor:
Nabi Biopharmaceuticals
Organization:
Study Overview
Official Title:
Phase 3b Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Evaluating Immunogenicity and Safety of a 3rd and 4th Dose of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults With End-Stage Renal Disease
Status:
TERMINATED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
unsatisfactory efficacy data from preceding trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHIELD-2
Brief Summary:
This study is a continued evaluation of the immune response to StaphVAX , a Staphylococcus aureus type 5 and 8 capsular polysaccharide conjugate vaccine, in end-stage renal disease patients, by giving a 3rd and 4th dose to a subset of the participants in the previous efficacy trial. Participants continue to receive the vaccine or placebo in a blinded manner, and are also randomly assigned to 1 of 2 different intervals between the doses. The immunogenicity is measured by the antibodies in the blood, and typical vaccine safety information is also collected.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: